Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04170946

Talazoparib and Thoracic RT for ES-SCLC

Led by University Health Network, Toronto · Updated on 2026-03-05

24

Participants Needed

1

Research Sites

360 weeks

Total Duration

On this page

Sponsors

U

University Health Network, Toronto

Lead Sponsor

P

Pfizer

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a phase I, dose escalating study evaluating the safety of combining talazoparib and low dose consolidative thoracic radiotherapy for small cell lung cancer patients. This study will also determine the maximum tolerated dose (MTD) of talazoparib in combination with low dose thoracic radiotherapy. Patients will start on talazoparib on day 1 of study intervention, and will continue to orally take talazoparib until the last day of radiation therapy. Up to 24 patients will be enrolled to the study, where the first 3 patients will start with a starting dose level of talazoparib is 0.5 mg PO once daily. This will increase to 1mg daily with each new cohort.

CONDITIONS

Official Title

Talazoparib and Thoracic RT for ES-SCLC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histological diagnosis of small cell lung cancer confirmed by a pathologist
  • Documented extensive disease
  • Completed 4 to 6 cycles of induction chemotherapy with a platinum agent and etoposide
  • No disease progression after chemotherapy (stable disease or better by RECIST 1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 or Karnofsky Performance Score of 50 or higher
  • Adequate organ and marrow function
  • For women of childbearing potential, postmenopausal status or negative pregnancy test within 28 days prior to treatment start
Not Eligible

You will not qualify if you...

  • Untreated brain metastases
  • Previous thoracic radiotherapy (breast radiotherapy allowed)
  • Receiving systemic chemotherapy, radiotherapy, or immunotherapy (except standard care or palliative) within 3 weeks before study
  • Exposure to investigational drugs within 30 days or 5 half-lives prior to study start
  • Prior treatment with any PARP inhibitor including talazoparib
  • Use of strong P-glycoprotein inhibitors or other P-gp/BCRP inhibitors/inducers
  • Persistent toxicities greater than grade 2 from previous cancer therapies (except hair loss)
  • Diagnosis or features suggesting myelodysplastic syndrome or acute leukemia
  • Major surgery within 2 weeks before treatment start without full recovery
  • Serious uncontrolled medical conditions or active infections
  • Unable to swallow oral medication or gastrointestinal disorders affecting absorption
  • Immunocompromised status
  • Previous allogenic bone marrow or double umbilical cord blood transplant
  • Blood transfusions within 120 days before study entry
  • Other malignancies within the last 5 years
  • Spinal cord compression

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Princess Margaret Cancer Center, University Health Network

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

B

Benjamin Lok, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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Talazoparib and Thoracic RT for ES-SCLC | DecenTrialz